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GENE TECHNOLOGY ETHICS AND COMMUNITY CONSULTATION COMMITTEE (GTECCC) DISCUSSION PAPER:
ENVIRONMENTAL ETHICS AS IT RELATES TO GENE TECHNOLOGY IN AUSTRALIA
Summary This paper arises out of discussions by the Gene Technology Ethics and Community Consultative Committee, which provides advice on ethical issues and on matters of general concern to the community to the Gene Technology Regulator in relation to genetically modified organisms, and its predecessor, the Gene Technology Ethics Committee. In reflecting on what people think about gene technology, the question arose as to what people think about the potential harms (or benefits) of gene technology for the environment, and what our duties are toward the environment. We then broke this issue down into two interrelated questions: (1) what ethical values do members of the public hold with regard to the environment, and (2) what does the Gene Technology Act 2000 (the main set of laws which governs gene technology in Australia) say with regard to these values? The first question has proven extremely difficult to answer, given the current state of information about what values people actually hold. We do know from philosophical literature on the subject of environmental ethics that there is a range of possible views and positions which therefore are reviewed in this paper. From this, it is clear that there is widespread disagreement about how much protection to give to the environment and at what cost to other values which we view as important. This paper also outlines the relatively limited treatment of environmental ethics and values within the Gene Technology Act 2000 , including how environmental protection should be defined, or even how we should define the environment itself. Hence it is clear that the Gene Technology Act 2000, as with much of environmental law, is not based on a clear, coherent set of ethical values. This paper has revealed that there should be ongoing investigation of community values in this area, and feedback of this information in the future as the Gene Technology Act 2000 is implemented and revised. Acknowledgements GTECCC would like to recognise the work of the following people in the development of
this paper:
The members of the environmental ethics working group‐Ms Judy Jones ex
officio member, Associate Professor Rachel Ankeny and Associate Professor
Vaughan Monamy. and
Chair of GTECCC‐Professor Don Chalmers.
1
Background to paper At the 10th meeting of the Gene Technology Ethics Committee (GTEC: 15 November 2005) a
working party was formed to examine various ethical approaches to gene technology with an
emphasis on how environmental ethics is distinct from medical ethics. GTEC deemed this issue to
be a high priority as the Gene Technology Act (2000) looks at the protection of the environment
but, at that time, GTEC had not considered exactly what that statement meant (Minutes of 10th
meeting).
Two secondary questions were posed:
(1) What can ecocentric ethics bring to gene technology? and
(2) What status do environmental goods have in ethics?
A discussion paper was prepared by Vaughan Monamy that addressed both these questions so
that GTEC could use it as a basis for determining how environmental ethics differed from medical
ethics.
Following discussion in early March 2006, GTEC asked the Working Party (originally Assoc. Prof.
Monamy and Assoc. Prof. Rachel Ankeny but with the addition of Ms Judith Jones) to further
examine issues on two levels:
‐ GTEC’s duty as defined by the Act, and
‐ The wider context of environmental ethics as it related to gene technology.
To this end, Judith Jones added a substantial section to the draft paper. The committee also
suggested that the Working party investigate the value of the document in terms of supporting
the National Framework for the Development of Ethical Principles in Gene Technology (National
Framework: GTEC 2006).
The draft paper was discussed at the first meeting of the Gene Technology Ethics and Community
Consultative Committee (GTECCC) in May 2008. GTECCC agreed that the draft paper should be
further developed. At its second meeting (February 2009), after considerable discussion, GTECCC
considered the paper in its current form to be complete for the primary purpose of providing
information to the Regulator and members of GTECCC. The paper was presented at the
Australasian Association of Bioethics and Health Law conference, Adelaide, July 2010 where
comments on the paper were invited.
What follows is the revised draft that takes into consideration input from conference attendees
and from subsequent discussion between the authors Judy Jones, Rachel Ankeny and Vaughan
Monamy.
2
The Objectives, Scope and Organisation of this Paper This paper seeks to:
1. Examine the main schools of philosophical thought and other approaches to
environmental ethics which may be applicable to gene technology and
2. Examine environmental ethics currently applicable to the Gene Technology
Act 2000 and to implementation of the Act.
Since each of these enquiries is potentially vast, boundaries have been set. Part One
provides an overview to various approaches in environmental ethics which raise issues
related to a range of gene technology activities (including what may be outside the
current scope of the Gene Technology Act 2000, which is primarily anthropocentric in its
focus). Part Two commences with interpretation of section 56 which creates the
primary statutory obligation on the Gene Technology Regulator not to issue a licence
unless satisfied as to risk management. From this flows consideration of other core
concepts of the Gene Technology Act 2000, such as the Object of the Act (section 3), the
definition of ‘environment’ and other key concepts within the legislation. It also
considers the Risk Analysis Framework (RAF: April 2009) as a core document of
relevance to implementation of the Gene Technology Act 2000 (primarily intentional
release). This analysis can be expanded subsequently to include other aspects of the
Gene Technology Act 2000 and implementation if desired.
Why Consider Environmental Ethics in Relation to the Gene Technology Act 2000 ? The Gene Technology Act 2000 is sometimes viewed simply as another example of a
statutory scheme that provides for environmental protection. However, closer
comparison of the Gene Technology Act 2000 with other regimes for environmental
impact assessment reveals that the Gene Technology Act 2000 has some fundamentally
different features when compared to other environmental laws that are also aimed at
(different forms of) risk regulation. This raises a very important question; are the
features of the Gene Technology Act 2000 so fundamentally different to the features of
mainstream environmental risk regulation that the Gene Technology Act 2000 ought to
be considered to express a unique environmental ethic or a unique set of values, at least
for an ‘environmental law’?
The lack of articulation of the values embedded in environmental laws One important point to note at the outset is that environmental laws, since the 1970s,
have operated without a precise or consistent articulation or statement of either the
3
values embedded in those laws or the motivation behind their enactment. Moreover,
even when the values are prima facie apparent, the values may perhaps be in conflict
and only resolved by decision‐makers exercising discretionary powers.
Furthermore, much environmental law scholarship (and scholarship on the Gene
Technology Act 2000 is no exception) has focussed on the content and operation of
those laws with only scant attention paid to the values or any environmental ethic
underlying them. Tarlock (2004) considered that “…there is no longstanding social
consensus about the central question of modern environmentalism – the ‘correct’
human stewardship relationship to the natural world” (Tarlock, 2004, pg. 223).
Disagreement exists on how much protection to give the environment and at what cost
to other values (Flournoy, 2003). It has been argued (e.g., Flournoy, 2003) that there
are good reasons for pursuing a refinement of our understanding of the ethical bases for
environmental law including assistance with public decision‐making where there are
ethical choices to be made.
1.0 REVIEW OF ENVIRONMENTAL ETHICS RELEVANT TO GENE TECHNOLOGY
Environmental Ethics is not a muddle; it is an invitation to moral development… An
ecological conscience requires an unprecedented mix of science and conscience, of
biology and ethics.”
Rolston (1991)
1.1 Preamble What follows is an introduction to some recognised approaches to environmental
ethics. Despite a longer history of ethical consideration of human’s relationship and
duties to their environment, it is clear that many people and society as a whole have
become increasingly concerned over the past 50 years about environmental issues.
Societal values are often rapidly changing and are sometimes difficult to identify
accurately, let alone articulating ethical theories or foundations that might underlie
these values. Few data are available to assess the Australian public’s views on their
preferred environmental philosophy particularly as it applies to a contested domain
such as gene technology, although there are some public opinion polls relating to
specific issues such as the surveys conducted by the now defunct Biotechnology
Australia (see http://www.biotechnology.gov.au). It could be argued that there has
been a general shift away from viewing humans as separate from and dominant over
the natural world, an approach that echoes economic approaches which see the
4
environment as a resource to be managed and used, but it is unclear how widespread
such a change has been or what the implications of such an approach are, particularly
for gene technology.
Hence the main question that remains is the perspective or point of view from which
environmental values are to be assessed. Most ecocentric approaches to environmental
ethics oppose outright the use of gene technology outside of the human biomedical
sphere. Nonetheless it is critical to include these perspectives in any comprehensive
discussion of environmental ethics in order to have these views on the table for
consideration as, for instance, there may still be underlying values that can be
articulated which are not incompatible with the generally anthropocentric approach to
environmental ethics contained in the Gene Technology Act 2000.
The Gene Technology Act 2000 seems to presuppose the somewhat uncontroversial
assumption that curiosity and subsequent invention are core aspects of human culture.
Historically, we have often looked for efficiencies and better ways to utilise the natural
world to our benefit, and as will be outlined below, this is in accordance with more
traditional, anthropocentric approaches to the environment.
1.2 Scientific Background Relevant to Environmental Ethics The modern environmental sciences (and principally ecology) draw upon many well‐
established scientific disciplines (e.g., physics, geology, biology, chemistry, mathematics,
and palaeontology). The environmental sciences seek patterns in ecosystems from
which predictions can be made, and base conclusions about future changes on data
collected at a single point in evolutionary and ecological time (our present) or
interpreted from the past but recognising the importance of understanding successional
processes (e.g., plant and animal successions in a time of variable fire regimes).
Modern environmental sciences demonstrate empirically that most species (all but the
most resilient) require healthy functioning ecosystems if they are to survive, and hence
it is critical to have a clear approach to fostering such ecosystems. All species modify
their local environment in some way (e.g., release of phenols by pine trees to stop
germination of other plant species, beavers building dams, coral polyps creating giant
reefs). However, unlike the vast majority of species, humans modify the environment
on a global scale. For example, humans currently have found uses for 95% of biological
resources that sequester energy as sunlight (plants) or derive their energy from those
plants (animals). All human beings require, among other things, access to food, water
5
and shelter, and the resources required to achieve these needs must come from the
natural world. Resources in the natural world are finite when viewed in the time scales
in which humans utilise them.
1.3 Overview of Environmental Philosophies Numerous environmental philosophies exist and differ primarily in the centrality
afforded to the human versus the non‐human world. Anthropocentric approaches view
it as permissible that the natural world be used for human ends, and view nature as in
some sense instrumental to those ends. Ecocentric philosophies recognise the natural
world as being important for its own sake, and hence having intrinsic value separate
from its potential uses by humans. There are advocates for the ethical recognition of
ecosystems regardless of whether they are of instrumental value to humans or not. One
shared concern among most environmental philosophies is whether the natural world
can continue to sustain all of humanity indefinitely given current exponential population
growth, present resource use, and lack of effective waste management.
1.3.1 Anthropocentric approaches Historically, there has been a widely‐held view in the Western tradition that as the only
legitimate moral agent, the human is the measure of all things. Its foundations can be
traced to the Old Testament and Judaism, and even further to Aristotelian and Stoic
discourse, and these beliefs were incorporated into Christianity and later in humanism.
According to this view, humans are divine (or at least special) and all other beings have a
lower status. Humans are considered worthy of special consideration (moral and
otherwise) because of any number of reasons (e.g., personhood, advanced self‐
consciousness, ability to gain knowledge about the world). As moral agents, humans
have responsibilities with regard to the environment in general and certain other
species in particular. This is evidenced in discussions about human well‐being and
stewardship, dominion and responsibility.
This relationship between humans and the environment is anthropocentric. In other
words, since moral values are exclusive to humans, value can only be attributed (e.g., to
the environment) because it is recognised by humans. Within this perspective, there are
three rough categories for describing the relationship between humans and their
environment: domination, co‐operation and conservation (the discussion that follows
draws closely on Fisher 2003).
6
The strongest among the anthropocentric approaches, which arises out of the Greek
and Judeo‐Christian philosophies described above, holds that humans should be able to
treat nature as they see fit, for instance as a resource to be utilised, and without any
moral judgements being attached to such actions except inasmuch as they might affect
moral agents (i.e., other humans). Humans may be able to modify and transform
nature, according to more radical approaches, or may only be able to use nature as it is
given, under some conservative views. The resonance with economic perspectives is
obvious, inasmuch as use and even exploitation of the environment as a resource is
permitted.
A second anthropocentric approach sees humans’ role as one of steward, which does
place some limits on permissible actions. Stewardship can range from caring for the
environment but also modifying it in order to improve it, which may be a relevant
consideration for gene technology. Although the environment is acknowledged to have
value and hence some sense of responsibilities toward nature is implicit, humans are
still the central focus.
Certain forms of an ethic of conservation can be considered as a third approach to
anthropocentrism. This is typically attributed to the conservationist Aldo Leopold (1949)
who claimed that the environment was being abused because of private interests and
ownership of land should be vested in the community. We should treat and use our
environment with respect, and a so‐called ‘land ethic’ grounded in both the laws of
nature and the conception of community interest, allows recognition of the complex
relationship between humans and their environment while still allowing humans to use
and modify the environment. (Certain ecocentric views also derive from Leopold’s
philosophy as will be discussed below.)
In summary, within all anthropocentric views, human impacts on the natural world are
morally right if they have consequences that are favourable to human well‐being or if
they implement (or defend) fundamental human rights. It is to humans that all duties
are owed, and our duty of care to aspects of the natural world is contingent on
furthering human goals including values and rights.
1.3.2 Ecocentric and other nonanthropocentric approaches Ecocentrism and other non‐anthropocentric approaches challenge anthropocentric
ethics by re‐defining the boundaries of ethical obligation to include species, ecosystems,
or even the biosphere as subjects of moral relevance. Some environmental
7
philosophers have argued for the expansion of our moral sphere beyond the biota to
include our planet as a whole and, in a few instances, the entire universe (Nash, 1990).
At their core, these approaches share the fundamental idea that humans should not be
considered above or outside the natural world. Instead, there is acknowledgement that
ascribing moral relevance to healthy functioning ecosystems will ensure the survival and
fulfil the evolutionary potential of most species (including humans without giving
primacy to their well‐being). They often make reference to values including
interdependence, spiritual harmony, and extensionalism (i.e., the treatment of the
environment as persons for the attribution of rights and other legal purposes).
Inherent in any discussion of ecocentric ethics is a denial of human superiority. This is
often motivated by asking two questions: “What is the morally relevant difference
between humans and non‐human organisms (usually interpreted to mean other
vertebrates)?” and “If there are no morally relevant differences, then why do we treat
non‐human organisms/animals and humans so differently?” Failure to agree on
answers to this question leads to discussion about expanding the moral sphere to
incorporate moral consideration of all animals and plants (e.g., Schweitzer’s (1965)
Reverence for Life), ecosystems (e.g., Taylor’s (1981) Respect for Nature), ecosystems
and the energetic systems that ensure biotic survival for all species including humans
(e.g., Leopold’s (1949) Land Ethic, Naess’s (1973) Deep Ecology, Warren’s (1990)
Ecofeminism, and Fox’s (1995) Transpersonal Ecology), and ultimately, the entire
cosmos (e.g., Nash’s (1990) Rights of Nature, Berry’s (1999) Viable Human).
1.3.2.1 Animal Ethics Adherents to animal‐centred approaches to environmental ethics usually cite Peter
Singer’s ‘equality of consideration of interests’ principle as applied via preference
utilitarianism (Singer 1975). In short, this approach expands the principle of the
‘greatest good for the greatest number’ to count some types of non‐human animals
among those beings given moral standing. Singer (1975), for instance, limits his moral
consideration to organisms considered by science to be sentient, and argues the division
where sentience begins to be somewhere between an oyster and a crab. Tom Regan
(1983) attributes moral worth to beings based on them being ‘subjects‐of‐a‐life,’ and
considers mentally‐normal mammals older than one year of age to be such beings. It is
the subject‐of‐a‐life that is worthy of moral consideration inasmuch as it has inherent
value; in order to respect such beings, they must be given rights.
8
1.3.2.2 Ecocentric Ethics Ecocentric ethical approaches focus on moral obligations which humans owe to plants,
animals, and micro‐organisms to promote their well‐being for their own sake because of
their intrinsic value. Additionally, moral recognition may be given to the connections
between ecosystems upon which biota rely, or the networks which link various
individuals within the ecosystem or environment. Ecocentric ethics tend to branch from
a brief statement by Leopold (1949) that claimed that, “… a thing is right when it tends
to preserve the integrity, stability, and beauty of the biotic community. It is wrong
when it tends otherwise.” Many ecocentric philosophies will also incorporate some
type of mysticism and/or spiritualism.
1.3.2.3 Global Ethics Global ethics focus on the moral consideration of the planet as a whole with prominent
advocates including Rockefeller (1992), Lovelock (1995) and Berry (1999). The Gaia
theory is the most readily recognised of these environmental philosophies. Gaia theory
proposes that our planet is a living being capable of maintaining its own health and well‐
being through a complex pattern of equilibria and disequilibria. Scientific aspects of
Gaia theory emphasise the interconnectedness of all biological and non‐biological
systems. Spiritual aspects of Gaia theory advocate a reverence for the entire planet and
or affording her appropriate moral status. f
1.3.2.4 Cosmological Ethics Cosmological ethics ascribe moral worth to all organic and inorganic matter in the
universe(s). Energy fields that sustain life (and non‐life when it manifests itself as
matter rather than energy) are also relevant in any discussion of cosmological ethics.
There is usually discussion of pantheism and/or panentheism (Harrison 1999) in
cosmological ethics. Recognition that the universe became self‐aware through human
consciousness is reflected in the writings of Nash (1990) and Berry (1999) who both
argue for the moral importance of the cosmos.
1.4 Implications and Discussion in Relation to Gene Technology Those who take a generally anthropocentric view toward environmental ethics are less
likely to oppose gene technology than those coming from an ecocentric position. For
many who take an anthropocentric perspective, gene technology can be viewed as
another tool which either resembles previous low‐tech means of modifying nature or
which differs from earlier technologies in that it has the potential to rapidly create new
strains of living organisms that may impact on ecosystems. Where there is community
9
concern, ethical consideration has tended to focus on consequentialist and
deontological arguments, such as intrinsic objections to genetic modification and/or risk
assessment, which make reference to potential harms (and/or lack of benefit) for
humans. More acceptable uses of gene technology seem to be those that promise
numerous direct benefits for human health, including humane use of animals
(principally mice) for experimentation which is viewed by many as an inescapable
necessity (though this is debated by many animal rights scholars and activists).
Ecocentric approaches share in common an emphasis on the moral value of non‐human
species and their ecosystems. Radical ecocentrism as well as many forms of global and
cosmological ethics might well hold that nature should never be altered or modified,
particularly for human benefit alone, in which case all forms of gene technology (and
much plant breeding) would be morally impermissible. Less radical advocates of
ecocentrism would likely argue that equality of consideration ought to be given to non‐
humans and ecosystems to various extents. So, for instance, as it is morally wrong to
interfere with the welfare, behaviour, or rights of a human without first obtaining
consent, so too should non‐human animals and other organisms be given at least
equality of consideration. As consent cannot be granted by any non‐humans, many
would hold that genetically‐modified organisms should not be created or released into
the natural world. A more liberal position might allow some form of substituted
judgment or legal mechanisms for protection of such organisms and the environment,
but such a position would often generate institutional mechanisms that would cause
collapse into an anthropocentric perspective (an exception might be Stone’s (2010)
proposal for mechanisms for recognising and enforcing legal rights of natural objects).
2.0 THE GENE TECHNOLOGY ACT 2000 AS AN AUSTRALIAN ENVIRONMENTAL RISK ASSESSMENT REGIME: UNIQUE STATUTORY FEATURES AND IMPLIED VALUES
2.1 Methodology 2.1.1 A method for determining the underlying ethic of environmental laws
The general method for discovering the underlying environmental ethic of any piece of
environmental legislation is statutory interpretation of the language of the statute and
regulations. Analysis of statutory language to discover an environmental ethic involves
a range of legal and non‐legal tasks viz (i) legal analysis in the form of statutory
10
interpretation but also (ii) elaboration of values embedded within that language from
which (iii) plausible justifications are derived (Flournoy, 2003).
Determination of an environmental ethic within a regulatory regime is also not limited
to an analysis of statutory language. Rather, determination of the ethics and values
expressed through social institutions involves consideration of not only statutory
sources but also mechanisms of implementation including guidelines, operational
manuals and exercise of discretionary powers.
2.1.2 A method for determining the environmental values underpinning the Gene
Technology Act 2000
Following this general method, the method adopted in this paper to consider values
underpinning the Gene Technology Act 2000 is to analyse statutory language of the Act
itself and also to examine values that emerge from the law in action, as implemented
within discretionary frameworks in public administration (such as reflected in the Risk
Analysis Framework, [RAF]), April 2009).
Subjecting the wording of the entire Gene Technology Act 2000 and the Gene
Technology Regulations, the implementation procedures and the actions of the Office of
the Gene Technology Regulator (OGTR) to analysis would be an immense project.
Consequently, a single primary operative section, section 56 has been selected as a
preliminary starting point for analysis of the values underpinning the Act.
Section 56 is a very important section as it creates the primary statutory obligation on
the Regulator not to issue a licence unless satisfied as to risk management. Interpreting
this important section of the Act, in context, requires consideration of other core
concepts of the Gene Technology Act 2000, such as the Object of the Act (section 3), the
definition of ‘environment’ and other key concepts within the legislation. This analysis
also considers the RAF (April 2009) as a core document of relevance to implementation
of the Gene Technology Act 2000. The inquiry could be expanded to consider individual
Risk Assessment and Risk Management Plans (RARMPs). Other sources that could be
considered as part of an expanded inquiry are the historical context (including the
operation of the Genetic Manipulation Advisory Committee and impetus for regulatory
reform), the explanatory memorandum to the Gene Technology Act 2000 and
documented public consultation both prior to enactment of the Gene Technology Act
2000 and also as part of the review of the Act (2005 ‐ 2006). Since all of these sources
are highly relevant to determining the values and motivation behind the legislative
11
scheme, and have not yet all been incorporated, the statutory analysis that follows
should be regarded as a starting point.
2.2 Analysis 2.2.1 Section 56, Gene Technology Act 2000 Section 56 (1) provides:
“The Regulator must not issue the licence unless the Regulator is satisfied that any risks
posed by the dealings proposed to be authorised by the licence are able to be managed in
such a way as to protect:
(a) the health and safety of people; and
(b) the environment.”
The thematic structure of the analysis that follows picks up on the fundamental
elements of Section 56 which are:
What can decision‐makers consider? What is included and excluded from the
Regulator’s consideration?
the definition of “environment”, and
the obligation “to protect”, and
the obligation to “manage risk.”
The latter three elements namely “environment”, “to protect” and “manage risk”
appear not only in section 56, but are also duplicated in section 3, the Objects of the
Act.
“Section 3: Object of Act
The object of this Act is to protect the health and safety of people, and to protect the
environment, by identifying risks posed by or as a result of gene technology, and by
managing those risks through regulating certain dealings with GMOs.”
2.2.2 What can decisionmakers consider? What is included and excluded from consideration? One notable feature of mainstream environmental law (such as in environmental impact
assessment) is that economic and social considerations are consistently placed in direct
12
competition with environmental objectives (including for example in some conceptions
of ecologically sustainable development). The Environment Protection and Biodiversity
Conservation Act 1999 (the ‘EPBC Act’) makes it mandatory for the decision‐maker to
consider the economic and social impact of a development as well as environmental
considerations.1
In contrast, section 56 of the Gene Technology Act 2000, consistent with the remainder
of the Gene Technology Act 2000, does not allow consideration of economic and social
considerations in decision‐making by the Gene Technology Regulator when issuing a
licence. This means that issues relating to trade and benefits of gene technology are
outside the scope of the Act. This is clearly expressed in the RAF (April 2009, page 16)
which states: “…Certain issues, such as impacts on trade, social and cultural effects, as
well as benefits that may be derived from gene technology or food labelling, are outside
the scope of the analysis.”
It was also noted in the earlier version of the RAF (November 2007, para 46) that
extensive stakeholder consultation “…made it clear that the community wanted the
regulatory system to focus exclusively on the evaluation of risks to human health and
safety and the environment. This was to prevent economic considerations (eg, cost‐
benefit analyses, market access and agricultural trade implications), from compromising
the regulatory system’s focus upon the scientific evaluation of risks and the protection
of human health and safety and the environment”. When compared to all other
environmental laws this feature of the Gene Technology Act 2000 is a significant
privileging or elevation of environmental values over economic and social benefits and
values.
2.2.3 Definition of “environment”
What is the environment that the Regulator is obliged to consider and “protect”?
The starting point is an examination of the text of the Gene Technology Act 2000 and the
text of the RAF (April 2009). Statutory interpretation of “environment” for the purposes
of the Gene Technology Act 2000 is assisted by inclusion of a definition within Section 10
of the Act which states:
“Environment includes:
(a) ecosystems and their constituent parts; and
(b) natural and physical resources; and
1 See for example, the Environment Protection and Biodiversity Conservation Act 1999 (Cth), section 136(1)(b).
13
(c) the qualities and characteristics of locations, places and areas.”2
The RAF (April 2009) provides some examples of environmental components that will be
considered in environmental risk assessment. On pg. 5, following discussion of the
definition of the environment, it is noted:
“Risk to the environment includes consideration of effects on biotic and abiotic
components of the environment”.
Biotic components include reduced “biodiversity” and abiotic components include “soil,
water, or air”.
So far, there is nothing remarkable about this characterisation of the environment when
compared to other environmental regulation (including the EPBC Act) – many of which
refer to biodiversity in similar terms. But what kind of bio‐diverse environment is
envisaged?
One of the common assumptions made about environmental policy and law is that it
seeks to protect and maintain the environment in a pristine ‘natural’ or unmodified (by
humans) state. However, closer scrutiny of general environmental policy and law
reveals that it seeks to satisfy a range of competing social, economic and environmental
interests – and ultimately only provides limited environmental guarantees.
Arguably, the Gene Technology Act 2000 also does not use the pristine environment as
its reference point for protection. Indeed, the Gene Technology Act 2000 refers, in its
definition, to “natural and physical resources” expressly acknowledging that in the Gene
Technology Act 2000, as in other environmental law statutes, the environment is a
resource. Furthermore, on a globe populated by seven billion people it is very difficult
to find an unmodified environment – and Australia is no exception. While it is of course
a question of degree, one only needs to consider increased atmospheric carbon dioxide
levels or increased seasonal UV levels due to the hole in the ozone layer over the
Antarctic to appreciate how difficult it is to find an environment that remains
unmodified by human activities. This policy and regulatory landscape is a very
important context when considering the environmental ethics or philosophy that
underpin provisions of the Gene Technology Act 2000.
2 As noted in the RAF (April 2009, para 43) this definition is less inclusive than the definition of the environment contained within the Environment Protection and Biodiversity Conservation Act 1999 (Cth). That definition includes social, economic and cultural matters whereas they are not included here under the Gene Technology Act 2000. This point has been discussed above.
14
2.2.3.1 The Relevance of the Agricultural Environmental Baseline to the meaning
“Environment” within the Gene Technology Act 2000
In the preceding section it was noted that much of the environment is modified by
humans. One such modified environment is the agricultural environment. This is an
important ‘environment’ or context for the purposes of the Gene Technology Act 2000
because many current gene technology applications for intentional release, such as
genetically‐modified cotton and genetically‐modified canola, do have distinct
agricultural applications.
Agricultural activities are relatively unregulated in Australia – at least in terms of direct
regulation. Landowners have historically had a free choice as to any agricultural
enterprise adopted – although, indirectly, some forms of regulation may have a large
bearing. For example, at State level, the siting of intensive agriculture such as feedlots
will invoke development approvals and pollution controls; growing of irrigated crops will
invoke water licensing regulation; and land clearing will require development approval.
At the Federal level the Australian Pesticides and Veterinary Medicines Authority
regulates insect resistant genetically‐modified organisms as agricultural products (‘plant
pesticides’) and considers product efficacy (i.e., the emergence of insect resistance). If
regarded as a “matter of national environmental significance” the activity would need
Federal approval pursuant to the EPBC Act. So, although there is some indirect
regulation and also some properties are managed more sustainably than others,
environmental regulatory obligations are limited and the agricultural environment is,
generally speaking, a highly modified environment.
What then, does the Gene Technology Act 2000 suggest as the relevant baseline
environment? Section 15 AA of the Acts Interpretation Act 1901 (Cth) permits recourse
to the purpose section of a statute to assist with interpretation of a provision (such as
section 56). In section 3 (Object of Act) the Gene Technology Act 2000 refers to the risks
“posed by or as a result of gene technology”.
As noted in the RAF (April 2009; page 19):
“In particular, the Regulator identifies risks posed by or as a result of gene
technology by using comparative risk assessment methodology. Therefore risks
posed by a particular GMO need to be considered in relation to the parent
organism in the receiving environment. For example, non‐GM crop species
already present risks to the health of people (for example, gluten in wheat or
15
allergens in soybeans or peanuts) or to the environment (for example, some
pasture species have a degree of weediness). These risks associated with the
parent organism form part of the baseline against which the GMO is assessed to
determine whether gene technology has increased the level of risks or poses
additional risks.”
Because genetically‐modified organisms are currently being released in agricultural
environments, a number of agricultural examples will be utilised to illustrate the scope
of the Gene Technology Act 2000 and OGTR deliberations.
(a) Agricultural Sustainability
Cotton has been grown for several decades in the Australian agricultural sector in an
unmodified form (subject, of course, to modification through traditional plant breeding)
(see further ‘The Biology and ecology of cotton (Gossypium hirsutum) in Australia’
(OGTR website). Current agricultural practices, including, for example, the use of
insecticides in cotton growing have detrimental environmental impacts, having a
detrimental impact on non‐target species. Insecticide use and consequently its negative
environmental effect will be changed by the growing of genetically‐modified cotton
(cotton containing an insecticide). In addition, the mere fact that cotton crops are
grown at all, e.g., irrigated cotton, have a significant environmental impact. This is
starkly illustrated by the example of the environmental effects of growing any type of
irrigated cotton in the Murray‐Darling Basin. Arguments have been made that the OGTR
should look at the environmental impact of cotton growing per se rather than simply the
environmental impact of genetically‐modified cotton. However, such an approach to
the Gene Technology Act 2000 would not be consistent with the assessment of risks that
are “…posed by or as a result of gene technology…” as required by the Gene Technology
Act 2000 (s 3).
(b) Harmfulness to other Organisms – target and non‐target
Does the Gene Technology Act 2000 oblige the protection of native invertebrates or
other native organisms such as plants as part of the ecosystem or environment it seeks
to protect? What if a genetically‐modified organism has a detrimental effect on native
species (e.g., native invertebrates that are considered pests to agriculture)? Indeed, in
some agricultural applications of gene technology the aim of the genetically‐modified
organism, such as an insecticidal agricultural plant, will be the mortality of such
invertebrates. Furthermore, what if the genetically‐modified organism that has an
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indirect detrimental effect on native species, e.g., native vertebrates (birds) that feed on
the invertebrates? Is such ‘collateral damage’ part of the risk to the environment that
has to be managed or avoided?
Thus, statutory interpretation of the definition of the “environment” assisted by Section
3 of the Gene Technology Act 2000 (and as interpreted by the OGTR in the RAF (April
2009)) suggests that the agricultural environmental baseline or environmental ‘status
quo’ is very relevant. This is also a pragmatic and consistent approach. First, it seems
reasonable to recognise that the current environment is an environment that has been
modified by humans. Secondly, as noted above, elevation or tolerance of agricultural
values is consistent with the philosophy underpinning other forms of well‐accepted
environmental regulation.
2.2.4 Obligation “to protect”
‐ Statutory Guidance in the Gene Technology Act 2000
Another important feature to expand our understanding of the ethical bases or values
embedded in the Gene Technology Act 2000 is the obligation “to protect” the
environment. Mandatory statutory provisions prevent the Regulator from issuing a
license unless satisfied that risks can be managed in a manner that will “protect …the
environment” (sections 56 (1) and also 51(2) (a)). “Protect” is not defined in the Act.
In the absence of a definition of “protect” within the Gene Technology Act 2000
recourse to a dictionary for the purposes of statutory interpretation is permitted (State
Chamber of Commerce v Commonwealth (1987) 163 CLR 329 at 348). The Australian
Oxford Dictionary (1999) defines “protect” as “keep safe; defend; guard”. But what
does this mean in terms of statutory environmental protections?
What does the notion “to protect” require? Is this protection offered by the regime(s)
protection of the species, ecosystem or community or of individuals of the species,
ecosystem or community? Again, comparison with other environmental laws is useful
as a starting point.
‐ Comparisons with the EPBC Act.
Regardless of the fact that the word “protection” is contained in the title to the
Environment Protection and Biodiversity Conservation Act 1999, the level of protection
that this statute can provide is arguable. This is because, as noted above, the decision‐
maker under the EPBC Act is not only authorised, but is required, to take into account
economic and social considerations as well as environmental matters.
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But the legislation does provide indirectly a higher level of protection for some
individuals – those that are members of threatened or endangered species or
communities. Regulatory regimes, such as the EPBC Act (and equivalent legislation in all
States and Territories) do recognise the so‐called threatened or endangered species or
ecological communities, and these ‘species’ or ‘communities’ may be given a higher
level of protection. And, if the species or community is threatened, then the individuals
of the species or community (or the individual communities) will be protected in order
to protect the species or community.
To obtain this recognition, and higher level of protection, threatened species or
ecological communities must be expressly listed or described in a Schedule to the EPBC
Act. However, listing of a species in this manner does not guarantee its protection or
preservation. Rather, the higher level of protection is simply that there will be a higher
level of environmental impact assessment prior to making a discretionary decision
(which also expressly incorporates social and economic considerations). Thus, the
general approach in environmental law is to provide a higher level of procedural
scrutiny in the assessment of potential harm for individuals of a threatened species or
ecological community. If a community or species is considered to be of sufficient
‘worth’, then an area will be gazetted as a Nature reserve, National Park or even a
World Heritage Area. Creation of nature reserves potentially accords/affords a higher
level of protection within these areas. However, the protection of threatened species or
ecological communities in off‐reserve locations (pursuant to the EPBC Act) is never
guaranteed since the decision‐maker is also required to take economic and social
considerations into account in determining management plans for listed species and
communities. Thus, the effect of the legislation is that decision‐makers conduct a more
intense scrutiny of the potential impact of a proposed development on threatened
species or ecological communities but the protection of such species/communities is not
guaranteed.
The Gene Technology Act 2000 contains a higher duty of protection when compared to
other environmental law statutes
It is clear that the express obligation to “protect”, combined with the exclusion of
economic and social considerations from section 56 of the Gene Technology Act 2000
creates a much higher duty to protect, than is provided by mainstream environmental
risk assessment.
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The RAF (April 2009) provides considerable insight to the interpretation of
environmental protection by the OGTR – and that interpretation is consistent with the
general approach in environmental law described above, particularly in relation to
differential treatment of individuals versus treatment of species or communities. For
example, (p 30) it is noted that:
“Harm to humans is usually considered at the level of an individual, whereas
harm to the environment is usually considered at the level of populations, species
or communities.”
In terms of values underpinning implementation of the Gene Technology Act 2000, this
analysis suggests that, consistent with the EPBC Act, individual organisms are not valued
whereas entire groupings of entities are valued. This is consistent with current
regulatory approaches to biodiversity conservation which, as discussed above, focus on
habitat and ecosystem protection rather than protection of individuals.
This discussion of the EPBC Act serves to highlight how different the Gene Technology
Act 2000 is from mainstream environmental law in a couple of very important ways.
The Gene Technology Act 2000 obliges the OGTR not to take economic and social
interests into account (for example, trade related aspects are excluded from
consideration). Similarly, the OGTR cannot consider benefits – presumably, also, not
being able to consider the environmental benefits of gene technology.
2.2.5 The obligation to “manage risk”
One further difference between the Gene Technology Act 2000 and mainstream
environmental law is that the obligation to manage risk appears prominently in the
Gene Technology Act 2000 and in other risk assessment regimes that originate in the
health and agriculture portfolios (therapeutic goods approval, chemicals regulation,
quarantine, etc) whereas environmental law remains silent on ‘risk’. Nonetheless,
despite the absence of any express reference to risk in statements of goals or
obligations in mainstream environmental law, there regimes are, in effect, managing
environmental risk. The significance of this difference between the two ‘environmental’
regimes deserves further analysis.
Likewise, it should be noted that while the statutory language in the Gene Technology
Act 2000 excludes economic and social considerations, the Act does require the
management of risk. All processes of risk analysis require judgments about what is an
'acceptable risk' and this has the potential to inject value‐laden judgments. The Risk
Analysis Framework to the Gene Technology Act 2000 does provide some indication as
19
to the values that have been adopted by the OGTR when assessing and managing the
risks of gene technology. This document explains how the risks to human health, safety
and the environment are assessed through a comparative methodology which expressly
adopts the modified environmental baseline as the relevant environmental reference
point (as explained in 2.2.3.1 above).
3.0 Conclusion As foreshadowed, this represents an initial examination of key statutory language within
the Gene Technology Act 2000 and some contextual documents, for the purposes of
gleaning values embedded in the regulatory regime. The inquiry could be expanded in
scope to include a more detailed analysis of the RAF and analysis of additional
contextual material such as the RARMPs.
The discussion has simply attempted to elicit some of the values underpinning the Gene
Technology Act 2000 and compared them to mainstream environmental laws enacted
ostensibly for the purpose of protecting the environment. The Gene Technology Act
2000 does have some features that make it a much stronger and more ‘protective’
regime than mainstream environmental law. This is perhaps because some of the
features of the regime have originated in the health risk assessment portfolios rather
than the environmental portfolio. If the Minister administering the EPBC Act decided to
destroy the last remaining individual or population of a species by allowing a
development on the basis of social or economic considerations it would be within
his/her authority to do so. However, the Gene Technology Regulator would not be at
liberty either to take these factors into account in making a decision, or to knowingly
permit environmental harm as an outcome.
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